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Safety and Immunogenicity of an Intranasal RSV Vaccine Expressing SARS-CoV-2 Spike Protein (COVID-19 Vaccine) in Adults | Clinical Trials | Clareo Health

UNKNOWNPHASE1

Safety and Immunogenicity of an Intranasal RSV Vaccine Expressing SARS-CoV-2 Spike Protein (COVID-19 Vaccine) in Adults

Phase 1, Open-Label, Dose-Escalation Study to Evaluate Tolerability, Safety, and Immunogenicity of an Intranasal Live Attenuated Respiratory Syncytial Virus Vaccine Expressing Spike Protein of SARS-CoV-2 in Healthy Adults Ages 18 - 69 Years

NCT04798001•Meissa Vaccines, Inc.

View on ClinicalTrials.gov

Summary

This study evaluates an investigational vaccine that is designed to protect humans against infection with SARS-CoV-2, the novel coronavirus causing COVID-19 disease. The investigational vaccine, MV-014-212, is a live attenuated vaccine against respiratory syncytial virus (RSV) that is expressing the spike (S) protein of SARS-CoV-2. MV-014-212 is administered as drops or a spray in the nose. Specifically, this study analyzes the safety of, and the immune response to, the vaccine when administered to healthy adults between the ages of 18 and 69 years who are seronegative to SARS-CoV-2 and have not received a prior vaccine against COVID-19.

Eligibility

Age

18 - 69 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy adults ≥18 and \<56 years (Cohort A) and ≥56 years and \<70 years (Cohort B) as determined at the day of signing informed consent
•SARS-CoV-2 RT-PCR (nasal swab) negative at Day 1 pre-dose
•Women of childbearing potential (WOCBP) or male subjects with partners who are WOCBP must agree to practice contraception during their study participation from the signing of informed consent for at least 3 months after the final MV-014-212 administration.
•Written informed consent

Exclusion Criteria

•Diagnosis of chronic pulmonary disease (e.g. chronic obstructive pulmonary disease, asthma, pulmonary fibrosis, cystic fibrosis). Resolved childhood asthma is not exclusionary.
•Immunocompromised state due to comorbidities or other conditions as detailed in the study protocol
•Nasal obstruction (including due to anatomic/structural causes, acute or chronic rhinosinusitis, or other causes)
•Receipt of any other SARS-CoV-2, other experimental coronavirus, or experimental RSV vaccine at any time prior to the study
•Healthcare worker, long-term care or nursing home facility resident or employee, member of an emergency response team, or other occupation with high risk of exposure to SARS-CoV-2, and those working outside the home in customer facing occupations (e.g. waiter, cashier or store clerk, public transportation or taxi driver)
•Positive serum pregnancy test during Screening and/or positive urine pregnancy test on Day 1
•Breastfeeding during any period of study participation
•Occupational or household exposure to children \<5 years of age or to immunocompromised persons
•Receipt of or scheduled to receive any other SARS-CoV-2 vaccine prior to Day 1. Once dosed with MV-014-212, subjects should not receive an authorized or approved COVID-19 vaccine until after the Day 57 visit (single-dose subjects) or the Day 92 visit (two-dose subjects)
•Any medical disease or condition that, in the opinion of the PI, precludes study participation. This includes acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial

Locations (2)

Johnson County Clin-Trials

Lenexa, Kansas, United States

Wake Research

Raleigh, North Carolina, United States

Key Dates

Start Date

April 12, 2021

Primary Completion Date

October 31, 2022

Completion Date

October 31, 2022

Last Updated

August 2, 2022

Enrollment

130

ESTIMATED participants

Conditions

Covid19

Interventions

Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 1, Single Dose, Intranasal Drops

BIOLOGICAL

Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 2, Single Dose, Intranasal Drops

BIOLOGICAL

Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Single Dose, Intranasal Drops

BIOLOGICAL

Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Two Doses, Intranasal Drops

BIOLOGICAL

Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Single Dose, Intranasal Spray

BIOLOGICAL

Contacts

Jay Lieberman, MD

CONTACT

3107538943 jay.lieberman@meissavaccines.com

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NCT04525716

Covid19Surgery

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 2, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Immunogenicity of an Intranasal RSV Vaccine Expressing SARS-CoV-2 Spike Protein (COVID-19 Vaccine) in Adults

Inclusion Criteria

Exclusion Criteria

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